Quality Management Digital Systems.
This department interfaces with all internal departments, other Sanofi sites, contract manufacturers, suppliers, corporate Quality and RA personnel and the site management team.
The QMS System owner (m/f) is responsible for the management of QMS systems to support quality processes and to ensure the validation compliance of computerized systems at Sanofi Geel.
He/She is there to:
- Manage, test, implement, train, trouble-shoot and continuous improvement of QMS systems to contribute to the efficient and effective functioning of the quality processes within Sanofi.
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develop, implement and execute validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- Ensure the validated status of computerized systems in compliance with cGMP at all times.
- Ensure projects (moderate scale & complexity) are managed in conjunction with all required Sanofi and cGMP regulatory standards.
- Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized systems.
- Responsible for the validation documentation through approval and implementation.
- Provide input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
- Investigate/troubleshoot moderately complex validation problems.
- Develop moderately complex protocols to ensure quality standards.
Required Skills & Qualifications
- minimum 3-5 years experience working in a Healthcare manufacturing environment –pharmaceutical sector.
- 2-4 years experience in a Computerized Systems validation environment.
- Project management experience.
- Good knowledge of quality management systems and quality processes.
- Good communication skills at organization, team and individual levels.
- Effective facilitator and training skills.
- Competent knowledge of Computerized Systems Validation.
- Knowledge of cGMP and 21 CFR Part 11 requirements in a regulated environment.
- Full understanding of relevant quality and compliance regulations.
- Able to execute project to plan.
- Capable of troubleshooting validation issues associated with projects, process development, etc.
- Fluent in Dutch and English
- You will get an open-ended contract at Sanofi with fringe benefits (meal vouchers, hospitalization insurance, group insurance, etc.)
- This position is in day shift with flexible hours
- A place in an international, changing and continuously growing environment